Risk management framework for nano-biomaterials used in medical devices and advanced therapy medicinal products

Elisa Giubilato; Virginia Cazzagon; Mónica J.B. Amorim; Magda Blosi; Jacques Bouillard; Hans Bouwmeester; Anna Luisa Costa; Bengt Fadeel; Teresa F. Fernandes; Carlos Fito; Marina Hauser; Antonio Marcomini; Bernd Nowack; Lisa Pizzol; Leagh Powell; Adriele Prina-Mello; Haralambos Sarimveis; Janeck James Scott-Fordsmand; Elena Semenzin; Burkhard Stahlmecke; Vicki Stone; Alexis Vignes; Terry Wilkins; Alex Zabeo; Lang Tran; Danail Hristozov

doi:10.3390/ma13204532

Risk management framework for nano-biomaterials used in medical devices and advanced therapy medicinal products

Elisa Giubilato
, Virginia Cazzagon
, Mónica J.B. Amorim
, Magda Blosi
, Jacques Bouillard
, Hans Bouwmeester
, Anna Luisa Costa
, Bengt Fadeel
, Teresa F. Fernandes
, Carlos Fito
, Marina Hauser
, Antonio Marcomini
, Bernd Nowack
, Lisa Pizzol
, Leagh Powell
, Adriele Prina-Mello
, Haralambos Sarimveis
, Janeck James Scott-Fordsmand
, Elena Semenzin
, Burkhard Stahlmecke

Vicki Stone, Alexis Vignes, Terry Wilkins, Alex Zabeo, Lang Tran, Danail Hristozov^*

^*Corresponding author af dette arbejde

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avis › Tidsskriftartikel › Forskning › peer review

55 Citationer (Scopus)

Abstract

The convergence of nanotechnology and biotechnology has led to substantial advancements in nano-biomaterials (NBMs) used in medical devices (MD) and advanced therapy medicinal products (ATMP). However, there are concerns that applications of NBMs for medical diagnostics, therapeutics and regenerative medicine could also pose health and/or environmental risks since the current understanding of their safety is incomplete. A scientific strategy is therefore needed to assess all risks emerging along the life cycles of these products. To address this need, an overarching risk management framework (RMF) for NBMs used in MD and ATMP is presented in this paper, as a result of a collaborative effort of a team of experts within the EU Project BIORIMA and with relevant inputs from external stakeholders. The framework, in line with current regulatory requirements, is designed according to state-of-the-art approaches to risk assessment and management of both nanomaterials and biomaterials. The collection/generation of data for NBMs safety assessment is based on innovative integrated approaches to testing and assessment (IATA). The framework can support stakeholders (e.g., manufacturers, regulators, consultants) in systematically assessing not only patient safety but also occupational (including healthcare workers) and environmental risks along the life cycle of MD and ATMP. The outputs of the framework enable the user to identify suitable safe(r)-by-design alternatives and/or risk management measures and to compare the risks of NBMs to their (clinical) benefits, based on efficacy, quality and cost criteria, in order to inform robust risk management decision-making.

Originalsprog	Engelsk
Artikelnummer	4532
Tidsskrift	Materials
Vol/bind	13
Nummer	20
Antal sider	29
ISSN	1996-1944
DOI	https://doi.org/10.3390/ma13204532
Status	Udgivet - okt. 2020

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Giubilato, E., Cazzagon, V., Amorim, M. J. B., Blosi, M., Bouillard, J., Bouwmeester, H., Costa, A. L., Fadeel, B., Fernandes, T. F., Fito, C., Hauser, M., Marcomini, A., Nowack, B., Pizzol, L., Powell, L., Prina-Mello, A., Sarimveis, H., Scott-Fordsmand, J. J., Semenzin, E., ... Hristozov, D. (2020). Risk management framework for nano-biomaterials used in medical devices and advanced therapy medicinal products. Materials, 13(20), Artikel 4532. https://doi.org/10.3390/ma13204532

@article{db52aa5797aa415aa76c9d3c674a0323,

title = "Risk management framework for nano-biomaterials used in medical devices and advanced therapy medicinal products",

abstract = "The convergence of nanotechnology and biotechnology has led to substantial advancements in nano-biomaterials (NBMs) used in medical devices (MD) and advanced therapy medicinal products (ATMP). However, there are concerns that applications of NBMs for medical diagnostics, therapeutics and regenerative medicine could also pose health and/or environmental risks since the current understanding of their safety is incomplete. A scientific strategy is therefore needed to assess all risks emerging along the life cycles of these products. To address this need, an overarching risk management framework (RMF) for NBMs used in MD and ATMP is presented in this paper, as a result of a collaborative effort of a team of experts within the EU Project BIORIMA and with relevant inputs from external stakeholders. The framework, in line with current regulatory requirements, is designed according to state-of-the-art approaches to risk assessment and management of both nanomaterials and biomaterials. The collection/generation of data for NBMs safety assessment is based on innovative integrated approaches to testing and assessment (IATA). The framework can support stakeholders (e.g., manufacturers, regulators, consultants) in systematically assessing not only patient safety but also occupational (including healthcare workers) and environmental risks along the life cycle of MD and ATMP. The outputs of the framework enable the user to identify suitable safe(r)-by-design alternatives and/or risk management measures and to compare the risks of NBMs to their (clinical) benefits, based on efficacy, quality and cost criteria, in order to inform robust risk management decision-making.",

keywords = "Life cycle, Medical device, Nano-biomaterials, Nanomedicine, Risk management, Safe-by-design",

author = "Elisa Giubilato and Virginia Cazzagon and Amorim, \{M{\'o}nica J.B.\} and Magda Blosi and Jacques Bouillard and Hans Bouwmeester and Costa, \{Anna Luisa\} and Bengt Fadeel and Fernandes, \{Teresa F.\} and Carlos Fito and Marina Hauser and Antonio Marcomini and Bernd Nowack and Lisa Pizzol and Leagh Powell and Adriele Prina-Mello and Haralambos Sarimveis and Scott-Fordsmand, \{Janeck James\} and Elena Semenzin and Burkhard Stahlmecke and Vicki Stone and Alexis Vignes and Terry Wilkins and Alex Zabeo and Lang Tran and Danail Hristozov",

year = "2020",

month = oct,

doi = "10.3390/ma13204532",

language = "English",

volume = "13",

journal = "Materials",

issn = "1996-1944",

publisher = "Multidisciplinary Digital Publishing Institute (MDPI)",

number = "20",

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Giubilato, E, Cazzagon, V, Amorim, MJB, Blosi, M, Bouillard, J, Bouwmeester, H, Costa, AL, Fadeel, B, Fernandes, TF, Fito, C, Hauser, M, Marcomini, A, Nowack, B, Pizzol, L, Powell, L, Prina-Mello, A, Sarimveis, H, Scott-Fordsmand, JJ, Semenzin, E, Stahlmecke, B, Stone, V, Vignes, A, Wilkins, T, Zabeo, A, Tran, L & Hristozov, D 2020, 'Risk management framework for nano-biomaterials used in medical devices and advanced therapy medicinal products', Materials, bind 13, nr. 20, 4532. https://doi.org/10.3390/ma13204532

TY - JOUR

T1 - Risk management framework for nano-biomaterials used in medical devices and advanced therapy medicinal products

AU - Giubilato, Elisa

AU - Cazzagon, Virginia

AU - Amorim, Mónica J.B.

AU - Blosi, Magda

AU - Bouillard, Jacques

AU - Bouwmeester, Hans

AU - Costa, Anna Luisa

AU - Fadeel, Bengt

AU - Fernandes, Teresa F.

AU - Fito, Carlos

AU - Hauser, Marina

AU - Marcomini, Antonio

AU - Nowack, Bernd

AU - Pizzol, Lisa

AU - Powell, Leagh

AU - Prina-Mello, Adriele

AU - Sarimveis, Haralambos

AU - Scott-Fordsmand, Janeck James

AU - Semenzin, Elena

AU - Stahlmecke, Burkhard

AU - Stone, Vicki

AU - Vignes, Alexis

AU - Wilkins, Terry

AU - Zabeo, Alex

AU - Tran, Lang

AU - Hristozov, Danail

PY - 2020/10

Y1 - 2020/10

N2 - The convergence of nanotechnology and biotechnology has led to substantial advancements in nano-biomaterials (NBMs) used in medical devices (MD) and advanced therapy medicinal products (ATMP). However, there are concerns that applications of NBMs for medical diagnostics, therapeutics and regenerative medicine could also pose health and/or environmental risks since the current understanding of their safety is incomplete. A scientific strategy is therefore needed to assess all risks emerging along the life cycles of these products. To address this need, an overarching risk management framework (RMF) for NBMs used in MD and ATMP is presented in this paper, as a result of a collaborative effort of a team of experts within the EU Project BIORIMA and with relevant inputs from external stakeholders. The framework, in line with current regulatory requirements, is designed according to state-of-the-art approaches to risk assessment and management of both nanomaterials and biomaterials. The collection/generation of data for NBMs safety assessment is based on innovative integrated approaches to testing and assessment (IATA). The framework can support stakeholders (e.g., manufacturers, regulators, consultants) in systematically assessing not only patient safety but also occupational (including healthcare workers) and environmental risks along the life cycle of MD and ATMP. The outputs of the framework enable the user to identify suitable safe(r)-by-design alternatives and/or risk management measures and to compare the risks of NBMs to their (clinical) benefits, based on efficacy, quality and cost criteria, in order to inform robust risk management decision-making.

AB - The convergence of nanotechnology and biotechnology has led to substantial advancements in nano-biomaterials (NBMs) used in medical devices (MD) and advanced therapy medicinal products (ATMP). However, there are concerns that applications of NBMs for medical diagnostics, therapeutics and regenerative medicine could also pose health and/or environmental risks since the current understanding of their safety is incomplete. A scientific strategy is therefore needed to assess all risks emerging along the life cycles of these products. To address this need, an overarching risk management framework (RMF) for NBMs used in MD and ATMP is presented in this paper, as a result of a collaborative effort of a team of experts within the EU Project BIORIMA and with relevant inputs from external stakeholders. The framework, in line with current regulatory requirements, is designed according to state-of-the-art approaches to risk assessment and management of both nanomaterials and biomaterials. The collection/generation of data for NBMs safety assessment is based on innovative integrated approaches to testing and assessment (IATA). The framework can support stakeholders (e.g., manufacturers, regulators, consultants) in systematically assessing not only patient safety but also occupational (including healthcare workers) and environmental risks along the life cycle of MD and ATMP. The outputs of the framework enable the user to identify suitable safe(r)-by-design alternatives and/or risk management measures and to compare the risks of NBMs to their (clinical) benefits, based on efficacy, quality and cost criteria, in order to inform robust risk management decision-making.

KW - Life cycle

KW - Medical device

KW - Nano-biomaterials

KW - Nanomedicine

KW - Risk management

KW - Safe-by-design

UR - https://www.scopus.com/pages/publications/85090698288

U2 - 10.3390/ma13204532

DO - 10.3390/ma13204532

M3 - Journal article

C2 - 33066064

AN - SCOPUS:85090698288

SN - 1996-1944

VL - 13

JO - Materials

JF - Materials

IS - 20

M1 - 4532

ER -

Risk management framework for nano-biomaterials used in medical devices and advanced therapy medicinal products

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